The optimal treatment of midshaft clavicle fractures

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(1)THE OPTIMAL TREATMENT OF MIDSHAFT CLAVICLE FRACTURES. Denise van der Ven. THE OPTIMAL TREATMENT OF MIDSHAFT CLAVICLE FRACTURES Denise van der Ven.

(2) THE OPTIMAL TREATMENT OF MIDSHAFT CLAVICLE FRACTURES Denise van der Ven.

(3) The optimal treatment of midshaft clavicle fractures PhD Thesis, University of Twente, The Netherlands Copyright © D.J.C. van der Ven, 2018. All right reserved. No part of this thesis may be reproduced, stored or transmitted, in any form of by any means, without permission of the author. ISBN 978-90-365-4470-2 DOI is: 10.3990/1.9789036544702 https://doi.org/10.3990/1.9789036544702 Publication of this thesis was additionally supported by: Meander Medical Centre, University Twente Cover: Roy Sanders & Denise van der Ven Lay out: Roy Sanders Printing: Glideprint, Enschede, The Netherlands.

(4) THE OPTIMAL TREATMENT OF MIDSHAFT CLAVICLE FRACTURES De optimale behandeling van midschacht clavicula fracturen. PROEFSCHRIFT. ter verkrijging van de graad van doctor aan de Universiteit Twente op gezag van de rector magnificus, prof.dr. T.T.M. Palstra volgens besluit van het College voor Promoties in het openbaar te verdedigen op donderdag 15 februari 2018 om 14:45 uur. door. Denise Josephina Christina van der Ven Geboren op 11 juli 1990 te Maastricht.

(5) De promotor(en) Prof.dr. I.A.M.J Broeders De co-promotor(en) Dr. G.D.J van Olden Dr. T.K. Timmers.

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(7) Contents Chapter one. General introduction. 9. Part 1 - Fundamentals of clavicle fractures Chapter two. Definitions used in the management of clavicle fractures: can we actually compare study results?. 17. Chapter three. Musculoskeletal modeling of midshaft clavicle fractures by using finite element analysis. 39. Radiographic shortening is not a good indication for surgical intervention for midshaft clavicle fractures. 53. Chapter five. Plate fixation versus conservative treatment of displaced midshaft clavicle fractures: functional outcome and patients satisfaction during a mean follow-up of 5 years.. 67. Chapter six. Surgical versus conservative treatment of midshaft clavicle fractures in patients aged 16 years and older: a systematic review, meta-analysis and comparison of randomized controlled trials. 85. Chapter seven. Mini-invasive plate osteosynthesis (MIPO) using VALCP Anterior Clavicle Plate. 123. Chapter eight. Displaced clavicle fractures in cyclists: return to athletic activity after anteroinferior plate fixation. 139. Part 2 – Imaging Chapter four. Part 3 – Treatment.

(8) Part 4 – General discussion and summary Chapter nine. General discussion & future perspectives. 153. Chapter ten. Nederlandse samenvatting. 167. Chapter eleven. Review committee. 179. List of publications. 183. Acknowledgements. 187. Curriculum vitae auctoris. 195. Addendum 1. Conservative Treatment of displaced midshaft clavicular fractures: the measurement of shortening and its implications.. 199. Addendum 2. Biomechanical testing of anterior and superior plate positioning in midshaft clavicular fractures based on a finite elements model. 213. Addendum 3. Appendix Clavicle modeling. 227. Addendum 4. Rehabilitation protocol of conservative treatment. 251.

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(10) CHAPTER ONE. General introduction.

(11) General introduction. 1. Clavicle (n.) or “collarbone” originates in 1610s, middle French clavicule also “small key” from clavicula (used c. 980 in a translation Avicenna), which means tendril, door-bolt, or small key. Derived form the Latin word clavicula (a little key, key; vinetendril; pivot). The earliest know usage of clavicle in English dates from the 17th century. The bone rotates along its axis like a key when the shoulder is abducted and it is roughly the same shape as key from a Roman door lock.1 This refers to the anatomical structure including the s-shape of the bone and the “key” connection of the sternum with the shoulder girdle. The clavicle articulates at one end with the sternum and with the acromion of the scapula at the other, making it the only bony connection between the trunk and the upper limb.. History of treatment Early reports of clavicle fractures date back to Hippocrates (written 400 B.C.E) 2, who noted, “when a fractured clavicle is fairly broken across it is more easily treated, but when broken obliquely it is more difficult to manage”. He explained this theory as “for a bone fairly broken across can be more easily restored to its natural state, and with proper care the upper part may be brought down by means of suitable position and proper bandaging, and even if not properly set, the projecting part of the bone is not very sharp. But in oblique fractures the case is similar to that of bones which have been torn away, as formerly described; for they do not admit of being restored to their place, and the prominence of the bone is very sharp”. He is the first to describe the displacement of the fractured bone parts caused by the attached muscles, ligaments, and the weight of the arm. Furthermore, the importance of anatomical reposition and challenges that exist in treatment of displaced clavicle fractures. Based upon his theory Hippocrates stated that: “ It is of great importance that the patient should lie in a recumbent posture. Fourteen days will be sufficient if he keep quiet, and twenty at most.”2 Nowadays, we cannot imagine advising patients to lie down for weeks. Certainly, since clavicle fractures occur in a young and active population. Treatment of these fractures is, therefore, aimed at quickly restoring function and prevention disability. Throughout history there are several studies and theories that contributed to a better understanding of the biomechanics, normal bone physiology and fracture healing. Leading to the development and adjustments of different treatment strategies for displaced clavicle fractures.. 10.

(12) General introduction. Bone healing theories One of the first described bone healing theories are those of Wolff’s law3, Perren’s strain theory4 and Frost’s concept of the “mechanostat”.5. These theories consider the response of bone to the mechanical environment. Bone is a unique tissue that completely regenerates, rather than healing with a scar after injury like many other tissues. Wolff’s law of the transformation of bone (1892) describes the physiological response of normal bone to the mechanical environment during growth and remodeling. It explains interaction of bone to the applied stresses and its unique characteristic of altering its mechanical properties according to them. The application of this law to the clinical setting of fracture healing together with the interplay between parameters as implant rigidity, relative or absolute fracture stability, fracture gap size, and interfragmentary strain are all efforts to express and compute the complex phenomena of bone fracture repair. Perren’s theory (1978)4 deals with the physiological response of broken bone to the mechanical environment. Frost (1987)5 described bone homeostasis as a “mechanostat” responding to variations in the mechanical environment. To be able to understand these concepts is the mechanical response of bone tissue to strain. Strain is defined as: ‘a change in length of a material at a given mechanical load’. That load may be applied as compression, distraction or rotation (torsion).4 All living, biological material is subject to strain and we know some tissues respond to it. The strain tolerance of a tissue is the maximum strain at which a tissue will continue to exhibit normal physiological function.4 Beyond this level of strain, tissues will either fail to function normally or will fail. Every, limb, ligament, and muscle applies force and tension on the clavicle. The sternohyoid, pectoralis major and deltoid muscles find their origin on the clavicle; the sternocleidomastoid, subclavius and trapezius muscles insert on the clavicle. It is further connected to the coracoid process with the coracoclavicular ligament, to the first rib with the costoclavicular ligament, and to the contra lateral clavicle through the interclavicular ligament.6 The clavicle acts as a strut to enable motion of the arm and, therefore, is subjected to both tensile and compressive loads. The clavicle deflects with torsion or twisting because of the three-dimensional curvilinear-shaped structure. 7 Perren4 stated that the strain tolerance of lamellar bone is 2%. Beyond this, it will fracture. The bone-healing organ that then forms will differentiate with time through different tissues that can tolerate various levels of strain, with the granulation tissue that initially forms within a fracture site having a strain tolerance of 100%. The diamond concept of Giannoudis8 uses these mechanical theories as the basis for his concept of fracture healing. Describing the bone fracture healing as a diamond model with four. 11. 1.

(13) General introduction. 1. interactions. The fourth element; mechanical stability is essential for the formation of a callus that bridges the fracture site allowing loads to be transmitted across the fracture line. The progressive maturation of the fracture callus from woven to lamellar bone depends on this stability. Surgical interventions such as the application of systems of internal or external stabilization are designed to improve stability of fixation and thereby enhance healing. The other three keys are biological elements for fracture healing. A complex of interactions between: 1) the potent osteogenic cell populations; 2) the growth factors (osteoinductive stimulus); and 3) the osteoconductive matrix scaffolds.. Clinical studies In 1960 Neer 9 published the first clinical studies describing patients symptoms after treatment of clavicle fractures and complications such as nonunion. In his study he paraphrases the clavicle bone as a nonconformist. “It is the first bone to ossify in the embryo, and it continues throughout life to enjoy a remarkable reputation for its ability to form bone and heal”. In his studies he stated fractures of the middle and outer third should be seen as a different entity. He stated that no nonunion or as he called “ununited” fractures of the middle third are seen. All nonunions that occurred were in de outer third en due to tears of the coracoclavicular ligament. When this ligament was intact, prompt union was the rule. When nonunions occurred the cause should be sought in an inadequate operation technique; local tissue damage, removal of the valuable bone, soft part stripping, inadequate internal fixation and infection. Subsequently, midshaft clavicle fractures were treated conservatively with provision of a sling, collar and cuff or figure-of-eight bandage. In 1997, a study published by Hill et al.10 stated that closed treatment of displaced middlethird fractures of the clavicle gives poor results. After these results more studies found a higher rate of nonunion and mal-union after conservative treatment than previously thought.11 This caused a shift in the management of clavicle fracture towards a more operatively treatment strategy. Treatment mostly based on radiographic examination; amount of shortening and dislocation. In current literature, the long-term outcomes of these studies are raising new questions and causing discussion. Recent research has not shown convincingly that operative treatment is better for these kinds of fractures on the long term.12 Therefore, factors that are causing these misconceptions should be identified.. 12.

(14) General introduction. Thesis outline The aim of this thesis was to make a next step in the optimal treatment of displaced midshaft clavicle fractures. Where treatment is not solely based on radiographic examination. But working towards more patient oriented treatment and individualized strategies with the use of uniform definitions.. Part 1 – Fundamentals of clavicle fractures This first part of the thesis starts with the biomechanical principles of clavicle fractures and clavicle fracture management. The mechanical environment of the clavicle and the definitions used in clavicle management throughout literature are evaluated. In Chapter 2, the definitions used in current literature regarding clavicle fracture management are outlined. Although frequently used, no uniform definitions exist. There are numerous studies comparing functional outcome and complications, with definitions that vary significantly. Also, a wide variation in operation indications, the basis of a treatment strategy, is used. With this systematic review, we evaluated whether we can actually compare current study results. In Chapter 3, a musculoskeletal model is developed including all muscles and ligaments that find their origin or insertion at the clavicle bone. With this model a better understanding of the forces acting on the clavicle in intended. Giving more insight on the magnitude and direction of forces acting on the clavicle. Eventually, extrapolate these results to a better understanding of stable fixation and optimal positioning of the clavicle plate.. Part 2 – Imaging In the second module of this thesis presentation, the imaging of clavicle fractures is outlined. Most treatment is still based upon radiographic features of the fracture. Plain radiography is the most common way in which clavicle fractures are radiological assessed. Radiographic examination includes an anterior-posterior (AP) radiograph and a clavicle radiograph with some horizontal angle (15° - 45°). In Chapter 4, the used operation indications are evaluated. The currently described indications for surgical treatment as seen on radiograph examination are: complete displacement and clavicle shortening exceeding 15-20 mm. Since these factors have been reported in the literature to be associated with potential shoulder. 13. 1.

(15) General introduction. 1. dysfunction. This study questions whether operative treatment can be based on radiographic examination alone.. Part 3 – Treatment In the final part of this thesis, the treatment strategies are further investigated. In a cohort study of 97 patients we compared plate fixation with conservative treatment. In Chapter 5, the short term and long-term result of this cohort with a follow-up of five years are presented. Followed by a meta-analysis of treatment of midshaft clavicle fractures in Chapter 6. A systematic review and meta-analysis of all randomized controlled trials and observational studies in current literature regarding (operative or conservative) treatment of midshaft clavicle fractures was performed. Conservative treatment consists of provision of a sling, collar and cuff or figure-ofeight bandage during the initial phase and early mobilization (after one week) as the pain decreases. The standard surgical techniques for clavicle fractures are open reduction and internal plate fixation or intramedullary fixation. There are several complications described, such as deep infection, non-union, implant failure, refracture after implant removal, and poor cosmetic appearance. In Chapter 7, a new operation technique was described using minimal invasive plate osteosynthesis (MIPO). The main advantage of the (MIPO) technique is reduction of soft tissue disruption and preservation of blood supply to the fracture, which might enhance the healing process and reduce postoperative complications. Finally, in Chapter 8, the operative and rehabilitation strategy is extrapolated to an important (sub) group of patients. Return to athletic activity of cyclists after plate fixation is described.. 14.

(16) General introduction. REFERENCES 1.. https://yeditepeanatomy1.files.wordpress. com/2012/10/anatomy-monthly november2012-issue-2.pdf. 8.. Giannoudis PV, Thomas A. EinhornDavid Marsh Fracture healing: The diamond concept. Injury. 2007 Sep; 38 Suppl 4:S3-6.. 2.. Hippocrates. On The Articulations. 400 B.C.E.. 9.. 3.. Wolff J. Das gesetz der transformation der knochen. Berlin: Verlag von Augsut Hirschwald 1892. Neer CS. Nonunion of the clavicle. J Am Med Assoc 1960; 172: 1006-1011.. 4.. Perren SM, Boitzy A. Cellular differentiation and bone biomechanics during the consolidation of a fracture. Anat. Clin. 1978; 1:13-28.. 5.. Frost HM Bone “Mass” and the “Mechanostat”: A Proposal The Anatomical Record 1987: 219:1-9. 6.. Rowe CR. An atlas of anatomy and treatment of midclavicular fractures. Clin Orthop Relat Res. 1968;58:29-42.. 7.. Boresi AP, Schmidt RJ, Sidebottom OM. Deflection of curved beams. Advanced mechanics of materials. New York: Wiley & Sons; 1993. p. 385-91.. 10. Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle- third fractures of the clavicle gives poor results. J Bone Joint Surg Br 1997, 79:537-539. 11. Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicentre randomized clinical trial. J Bone Joint Surg Am 2007, 89:1-10. 12. McKee RC1, Whelan DB, Schemitsch EH, McKee MD. Operative versus nonoperative care of displaced midshaft clavicular fractures: a meta-analysis of randomized clinical trials. J Bone Joint Surg Am. 2012 Apr 18; 94(8): 675-84. doi: 10.2106/JBJS.J.01364.. 15. 1.

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(18) CHAPTER TWO. Definitions used in the management of clavicle fractures: can we actually compare study results?. D.J.C. van der Ven, D.P.J Smeeing, T.K. Timmers, J. Pogorzelski, P.J. Millett, F. Hietbrink, R.M. Houwert, O. A.J. van der Meijden Submitted.

(19) Part I - Fundamentals of clavicle fractures. ABSTRACT. 2. Background Even though there are numerous studies analyzing outcomes after operative fixation of clavicle fractures, the definitions used to describe (disorders of ) healing and complications vary substantially. Therefore, the aim of this systematic review was to identify and evaluate these published definitions. Study design Level III, Systematic review of Level I to Level III studies. Methods Published randomized controlled trials (RCT) and observational studies comparing either surgical and conservative treatment, or plate and intramedullary fixation for the treatment of acute midshaft clavicle fractures were included in this systematic review. The primary outcomes extracted were the definitions used for healing disorders: non-union, mal-union, and delayed union. Secondary parameters included the definitions of “fracture dislocation and shortening”, “implant related irritation”, and “infection”. Results Criteria total of 37 studies were included. Of those, 14 were RCTs and 23 studies were observational, consisting of eleven prospective and twelve retrospective studies. A wide variety in reported definitions was observed among the studies. Only 16 of 37 (43%) studies reported a definition for nonunion, 11 studies for mal-union and 5 studies did define delayed union. Twenty-three studies reported infections rates including a definition. Twenty-one studies defined implant related irritation as a complication. In 6 studies implant related irritation was followed by implant removal and in 15 studies this was unknown. Conclusion In the current literature concerning clavicle fracture treatment, a wide variety of definitions for fracture healing disorders, or complications exist. Until more consensuses are reached, we must be aware of the limitations of current data interpretation when comparing different studies.. 18.

(20) Definitions used in the management of clavicle fractures. INTRODUCTION Voltaire stated, “If you want to converse with me, first define your terms.”The optimal treatment of displaced midshaft clavicle fractures is a permanent topic of debate in current literature 23,50 and one of the reasons for this is the lack of standardized definitions. In the past few years, several systematic reviews and meta-analyses have been published comparing different treatment options for displaced clavicle fractures with contradicting results.4,18,34 Applied definitions of fracture union appeared to vary considerably amongst most of the studies. As a result, studies of patients with similar injuries undergoing similar treatment might report differences in time to heal due to different definitions of fracture union and not to the natural history of the disease or treatment. In general, the determination of fracture healing seems to be a highly subjective process and at present there is no consensus definition of nonunion in literature.17 This lack of agreement among clinicians and researchers poses an obstacle for clinical trials as the effectiveness of both standard and novel fracture healing therapies is fundamentally based on the demonstration of improved fracture healing. In addition, the use of inconsistent criteria to assess disorders of fracture healing across studies, further limits the generalizability of their results.12 Also, inconsistencies in definitions of possible indications for surgical treatment, such as fracture dislocation and shortening, have also been observed and may adversely influence the comparability of different studies.2, 3, 8, 19, 20, 26, 30, 31, 37, 43, 44, 46, 49, 51, 53, 43, 57, 58, 59-61,63 In general, uniformity in the use of definitions might aid in better interpreting study results and in the timing of possible secondary interventions. Therefore, the aim of this systematic review was to give an overview of the published definitions of healing, disorders of healing and complications used in clavicle fracture management and identify lack of consensus.. METHODS This systematic review was structured according to the PRISMA Checklist. No ethical committee approval was necessary for this literature review.42 Inclusion and exclusion criteria A literature search was performed focusing on studies reporting outcomes after midshaft clavicle fractures. Only randomized controlled trials (RCTs) and observational studies concerning the comparison of surgical and conservative treatment or the comparison of surgical fixation by plate or intramedullary fixation for acute midshaft clavicle fractures were included in this systematic review. Studies were excluded if they were not published in the English language.. 19. 2.

(21) Part I - Fundamentals of clavicle fractures. 2. Search strategy and selection criteria Published randomized controlled trials (RCTs) and observational studies concerning the comparison of surgical and conservative treatment or the comparison of surgical fixation by plate or intramedullary fixation for acute midshaft clavicle fractures were included in this systematic review. The search strategy was based on two recently published reviews from our research group. Reviewers searched Medline, Embase, CINAHL and the Cochrane library. Article written in English, French or German that were available in full text were included. A minimum follow-up time was not required for inclusion. Letters, comments, abstracts for conferences, case reports, study protocols, reviews, biomechanical studies, animal studies, studies that included patients with (only) floating shoulders, studies describing a surgical technique and noncomparative studies were excluded. Eligibility was resolved by discussion.23,50 The search syntax of both studies is provided in Appendix 1. On March 30, 2017, both search strategies were repeated to find additional studies published between 2016 and March 2017. Studies in which fracture healing or nonunion was not reported as outcome parameter were excluded for this review. The search syntax of both reviews is provided in Appendix 1. Data extraction The following data were extracted: first author, year of publication, study design, level of evidence, and outcomes parameters. The primary outcomes extracted were the definitions used for healing disorders: “non-union”, “delayed union”, and “mal-union”. Secondary parameters included the definitions of “fracture dislocation and shortening”, “implant related irritation”, and “infection”. Data extraction was performed by two independent reviewers (DV and DS). Disagreements were resolved by discussion with a third independent reviewer (RH). One included study, previously published by two of the authors (DV and TT), was assessed by two other reviewers (DS and RH).56. RESULTS Search The two previously published systematic reviews had included 40 studies.23,50 Six additional studies were found following an update of the search.7,44,48,49,63,64 After removing duplicates (3 articles), studies were screened full text for eligibility. Six studies were excluded because the articles did not report on our primary outcome parameter.7,21,32,33,63,65 Cross-referencing and citation checking did not result in additional studies. Therefore, 37 studies met the inclusion criteria. Of all included. 20.

(22) Definitions used in the management of clavicle fractures. studies 14 were RCTs, and 23 were observational, of which 11 were prospective studies and 12 were retrospective studies. Definitions in literature – Primary outcome parameters Healing disorders Sixteen studies of included 37 studies (43%) included a definition for nonunion. Eight (50%) studies used only radiological criteria and seven (44%) studies combined radiological criteria and clinical criteria. The clinical criteria used were pain and/or motion at the fracture site (Table 1). One (6%) study only included a time period. The time period for the diagnoses of nonunion varies from 4 months to one year after surgery. Mal-union rates were reported in 23 of 37 studies (62%), with 11 (48%) of these 23 studies actually defined malunion. One (9%) study used a radiographic criterium, 2 (18%) studies clinical criteria and 8 (72%) combined the 2. Six (54%) studies used the term “symptomatic” malunion in their definition (Table 2). The diagnosis for delayed union varies from 3 months to 1 year after trauma or surgery. Of the 15 studies, which included delayed union, 10 (67%) studies did not include a definition. (Table 3) Definitions in literature – Secondary outcome parameters Operation indication criteria Various definitions of indications for surgical treatment are reported (Table 4). A wide variety in classifications (i.e. Robinson/Edinburgh classification and AO classification) and descriptions for dislocation or displacement are used. Thirty-three (89%) studies did report dislocation as an operation indication. Ten (30%) studies did not define dislocation or used a classification that not includes dislocation (i.e. Orthopaedic Trauma Association classification). Only 7 (19%) studies did define shortening with different degrees of shortening leading to an unfortunate outcome are being reported; varying from 15-20mm. Twenty-four (65%) studies did not report shortening and 6 (16%) studies did report it, but did not use a definition for it. Implant related irritation Twenty-one (57%) studies defined implant related irritation as a complication. In 6 (29%) studies implant related irritation was followed by implant removal and in 15 (71%) studies it was unknown if implant related irritation was followed by a second operation to remove it. Thirteen (45%) studies did not report and 3 (8%) did not define implant related irritation. (Table 5) Two studies considered irritation a discomfort coexisting with the treatment and not a complication.45,50. 21. 2.

(23) Part I - Fundamentals of clavicle fractures. Table 1. Definitions of nonunion used in the literature Author Althausen et al.1. 2. Andrade-Silva et al.. Year. Study design. Definition of nonunion. Time period. 2013. RC. ND. ND. 2015. RCT. Fracture not healed. Six months. Assobhi et al.3. 2011. RCT. ND. ND. Böhme et al.. 2011. PC. ND. ND. 2007. RCT. The lack of radiographic healing with clinical evidence of pain and motion at the fracture site. One year. Chen et al.9. 2011. RCT. ND. ND. Chen et al.. 2012. RC. The presence of a complete gap at the fracture site. Six months. Daniilidis et al.13. 2013. RC. ND. ND. Dhakad et al. 16. 2016. PC. ND. ND. Ferran et al.. 6. COTS8. 10. 2. 2010. RCT. ND. ND. Fu et al. 20. 2012. RC. The lack of radiographic healing with tenderness on motion of the fracture site. Six months. Grassi et al.22. 2001. RC. ND. ND. Jones et al.26. 2014. RC. ND. ND. Jubel et al.. 2002. RC. ND. ND. 2009. RCT. ND. ND. 29. Kleweno et al.. 2011. PC. ND. ND. Khorami et al.30. 2014. PC. ND. ND. Kulshrestha et al.. 2011. PC. The lack of radiographic healing with clinical evidence of pain and crepitus at the fracture site.. Six months. Liu et al.36. 2010. RC. ND. ND. Mealean et al.37. 2015. RCT. Without radiologic signs of bone healing.. More than four months. Mirtazaloei et al.40. 2011. RCT. A lack of cortical bridging on radiography of the clavicle. Six months after surgery. Narsaria et al.43. 2014. PC. An unsuccessful healing of the bone, clinically manifesting as pain at the fracture site and radiologically as a visible gap between the fracture parts. Six months. Naveen et al.44. 2017. PC. ND. ND. Robinson et al.. 2013. RCT. The absence of radiographic union. Six months or longer after injury. 19. 27. Judd et al.28. 31. 46. 22.

(24) Definitions used in the management of clavicle fractures. Table 1. Continued Author. Year. Study design. Definition of nonunion. Time period. 2014. PC. ND. ND. Shetty et al.. 2017. RCT. ND. ND. Smekal et al.51. 2009. PC. Tabatabaei et al.53. 2011. PC. ND. ND. Tarng et al. 54. 2012. RC. ND. ND. ND. ND. Saha et al.48 49. 2. A lack of radiologic signs of osseous 24 week after consolidation with clinical evidence trauma of pain and motion at the fracture site. Thyagarajan et al.. 2009. RC. Van der Meijden et al.55. 2015. RCT. A lack of radiographic evidence of Six months after healing with clinical evidence of surgery pain and motion at the fracture. Van der Ven et al.57. 2015. PC. The absence of radiographic union. Six months. Virtanen et al. 58. 2012. RCT. The absence of periosteal and endosteal healing on radiographs. One year. Wenninger et al.59. 2012. RC. A lack of callus formation on two cortices on plain radiographs. Six months. Witzel et al.60. 2007. RCT. ND. ND. 2012. RC. An unsuccessful healing of the bone that clinically could be associated with pain and was visible on the radiograph as a gap between the fracture parts. Six months. 2017. RCT. The absence of complete osseous bridging of the fracture on the radiograph. More than six months. 55. Wijdicks et al.. Woltz et al. 64. 61. ND: no definition reported; PC: prospective cohort study; RC: retrospective cohort study; RCT: randomized controlled trial. 23.

(25) Part I - Fundamentals of clavicle fractures. Table 2. Definitions of malunion used in the literature. 2. Author. Year. Study design. Definition of malunion. Canadian Orthopaedic Trauma Society8. 2007. RCT. Radiographic: as loss of anatomic contour of the clavicle Symptomatic: union of the fracture in a shortened, angulated, or displaced position with weakness, easy fatigability, pain with overhead activity, neurologic symptoms, and shoulder asymmetry with a completed or planned corrective osteotomy. Chen et al.9. 2011. RCT. ND. Chen et al.. 2012. RC. A remarkable angulation of the clavicle compared with the uninjured side. 10. Dhakad et al.16. 2017. PC. ND. Ferran et al.19. 2010. RCT. ND. Fu et al.. 2012. RC. A loss of anatomic contour even in the presence of exuberant callus formation.. Judd et al.28. 2009. RCT. ND. Kulshrestha et al.31. 2011. PC. Union of the fracture in a shortened, angulated, or displaced position identified on radiographs together with cosmetic or functional complaints of the patient. Liu et al.36. 2010. RC. ND. Mirtazaloei et al.40. 2011. RCT. A malunion was considered as an adverse effect when patients with abnormal radiographic contour were symptomatic in terms of pain, weakness, or neurovascular symptoms.. Naveen et al.44. 2017. PC. ND. Robinson et al.46. 2013. RCT. ND. Saha et al.. 20. 2014. PC. ND. Shetty et al.49. 2017. PC. ND. Smekal et al.. 2009. PC. A loss of anatomic alignment of the clavicle and symmetry of the shoulder girdle. Symptomatic malunion with sequelae such as pain, easy fatigability and neurological symptoms and with the need for corrective osteotomy.. Tabatabaei et al.53. 2011. PC. ND. Thyagarajan et al.55. 2009. RC. ND. 2015. RCT. Fracture union in a shortened, angulated, or displaced position on radiographs with clinical symptoms. Van der Ven et al.57. 2015. PC. Symptomatic malunion: A patient with symptoms severe enough to warrant corrective osteotomy.. Virtanen et al.58. 2012. RCT. Symptomatic malunion: shortening of >20 mm, angulation, or displacement of the clavicle combined with sequelae such as pain, weakness, or a tendency to fatigue easily.. 48. 51. Van der Meijden et al.. 24. 56.

(26) Definitions used in the management of clavicle fractures. Table 2. Continued Author. Year. Study design. Definition of malunion. Witzel et al.60. 2007. RCT. ND. Wijdicks et al.61. 2012. RC. Symptomatic malunion: An incorrect anatomical position of the clavicle in comparison to the (healthy) side resulting in pain symptoms or a loss of function of the shoulder.. Woltz et al.64. 2017. RCT. Symptomatic malunion if secondary surgery was performed in an attempt to address symptoms thought to be related to deformity of the clavicle. ND: no definition reported; PC: prospective cohort study; RC: retrospective cohort study; RCT: randomized controlled trial Table 3. Definitions of delayed union used in the literature Author. Year. Study design. Definition of delayed union. Time period. Chen et al.9. 2011. RCT. ND. ND. Chen et al.. 2012. RC. Fracture union later than 24 weeks after trauma without any intervention. 24 weeks. Daniilidis et al.13. 2003. RC. ND. ND. Dhakad et al.. 2017. PC. ND. ND. Ferran et al. 19. 2010. RCT. ND. ND. Grassi et al.. 22. 2001. RC. ND. ND. Jones et al.26. 2014. RC. ND. ND. Judd et al.. 10. 16. 2009. RCT. ND. ND. Kleweno et al.29. 2011. PC. ND. ND. Khorami et al.. 28. 2014. PC. ND. ND. Kulshrestha et al.31. 2011. PC. ND. ND. Robinson et al.. 2013. RCT. Smekal et al.51. 2009. PC. Thyagarajan et al.55. 2009. RC. ND. ND. Van der Ven et al.57. 2015. PC. Progression to union on threedimensional CT. At one year of follow-up in patients who had not healed by six months. Virtanen et al.58. 2012. RCT. The absence of bridging callus and endosteal healing on radiographs combined with pain and/or instability in the fracture region. Three months. 30. 46. As defined as progression to union One year of follow-up on three-dimensional CT in patients who had not healed by six months As fracture union without further surgical intervention.. > 24 weeks after trauma. ND: no definition reported; PC: prospective cohort study; RC: retrospective cohort study; RCT: randomized controlled trial. 25. 2.

(27) Part I - Fundamentals of clavicle fractures. Table 4. Operation indication criteria Author. Year. Dislocation. Shortening. Althausen et al.. 2013. NR. NR. Andrade-Silva et al.2. 2015. Displacement of >2cm and/or no contact between the two fragments. NR. Assobhi et al.3. 2011. No cortical bone contact. Shortening of over 15mm. Böhme et al.. 1. 2 2011. NR. NR. Canadian Orthopaedic Trauma Society8. 2007. No cortical contact between the proximal and distal fragments. NR. Chen et al.9. 2011. ND. ND. Chen et al. 10. 2012. ND. NR. Daniilidis et al.. 2013. NR. NR. Dhakad et al. 16. 2016. NR. NR. Ferran et al.. 2010. ND. If there was complete overlap of bone ends or a displaced butterfly fragment. Fu et al. 20. 2012. Robinson classification 2B. NR. Grassi et al.22. 2001. ND. NR. Jones et al.. 26. 2014. Coronal displacement of at least 100%. A schematic figure was used to define shortening.. Jubel et al. 27. 2002. ND. NR. Judd et al.28. 2009. ND. ND. Kleweno et al.29. 2011. ND. NR. Khorami et al.30. 2014. Robinson classification 2B2,2B1. ND. Kulshrestha et al.31. 2011. No contact between the main fracture fragments. NR. Liu et al.36. 2010. ND. ND. Mealean et al.37. 2015. Without cortical contact. ND. 6. 13. 19. Mirtazaloei et al.. 2011. ND. ND. Narsaria et al.43. 2014. At least one shaft width difference in height betwee the fracture parts, regardless of the reduction. > 15mm. Naveen et al.44. 2017. Robinson type 2B. NR. Robinson et al.46. 2013. Edinbrugh type 2B. NR. Saha et al.. 2014. ND. NR. 2017. AO type A and B. NR. 40. 48. Shetty et al.49. 26.

(28) Definitions used in the management of clavicle fractures. Table 4. Continued Author. Year. Dislocation. Shortening. Smekal et al.. 2009. No cortical contact between the main fragments. NR. Tabatabaei et al.53. 2011. >2cm. >2cm. Tarng et al.. 2012. Type 2B2. NR. 2009. 100%. >2cm. 2015. At least one shaft width of distance on any radiograph between major fracture fragments, regardless of fracture shortening. ND. Van der Ven et al.57. 2015. No cortical contact between the proximal and distal fragment. NR. Virtanen et al. 58. 2012. Vertical displacement of an Difference in length between anteroposterior radiograph the injured and the uninjured was at least equal to the clavicle width of the clavicle, such that there was no cortical contact between the main diaphyseal fragments.. Wenninger et al.59. 2012. No contact between the main proximal and distal fragment. NR. Witzel et al.60. 2007. One third of the shaft or an angular velocity of more than 15 degrees on a AP radiograph. NR. Wijdicks et al. 61. 2012. At least one shaft width difference in height between the fracture parts, regardless of the reduction. NR. Woltz et al.64. 2017. At least 1 shaft (Robinson type 2B1 or 2B2. NR. 51. 54. Thyagarajan et al.55 Van der Meijden et al.. 56. 2. ND= no definition, NR= not reported. 27.

(29) Part I - Fundamentals of clavicle fractures. Table 5. Definitions of hardware irritation used in the literature. 2. Author. Year. Hardware irritation. Althausen et al. 1 Andrade-Silva et al. 2 Assobhi et al. 3 Böhme et al. 6. 2013 2015 2011 2011. NR ND Prominence of implant under the skin NR. Canadian Orthopaedic Trauma Society8. 2007. Hardware related (plate irritation and removal). Chen et al. 9. 2011. Telescoping: painful prominence of the medial protruding nail. Chen et al. 10. 2012. Patients complaint of irritation and some clinical sign, such as redness and swelling of the skin. Daniilidis et al. 13 Dhakad et al. 16 Ferran et al. 19 Fu et al. 20 Grassi et al. 22 Jones et al. 26 Jubel et al. 27 Judd et al. 28 Kleweno et al. 29 Khorami et al. 30 Kulshrestha et al. 31 Liu et al. 36 Mealean et al. 37. 2013 2016 2010 2012 2001 2014 2002 2009 2011 2014 2011 2010 2015. NR NR ND NR NR NR NR Prominence of the lateral aspect of the pin Prominent symptomatic pins NR Implant irritation required removal ND Local irritation or plate prominence. Mirtazaloei et al. 40. 2011. Narsaria et al. 43 Naveen et al. 44 Robinson et al. 46. 2014 2017 2013. Irritation and prominence of hardware, especially at the medial site. Patients insisted early removal of the plate NR Hardware prominence Local symptoms of hardware prominence. Saha et al. 48. 2014. Soft tissue irriation. Hardware prominence under the skin. 2017. NR. Shetty et al.. 49. Smekal et al. 51 Tabatabaei et al. 53. 2009 Medial skin irritation without telescoping with the need for cutting back the nail under local anaesthesia 2011 Patient complained of symptomatic hardware. Tarng et al. 54. 2012. Patient requesting implant removal due to skin tenting and irritation. Thyagarajan et al. 55 Van der Meijden et al. 56 Van der Ven et al. 57 Virtanen et al. 58 Wenninger et al. 59 Witzel et al. 60. 2009 2015 2015 2012 2012 2007. Prominent metal work causing discomfort Implant related problems (soft tissue irriation) Irritation requiring removal If fixation produced irritation Skin or soft tissue irritation NR. Wijdicks et al. 61. 2012. Assessed clinically and caused by prominence of the implant material of in case of TEN medial or lateral protrusion. Woltz et al. 64 2017 ND= no definition, NR= not reported 28. NR.

(30) Definitions used in the management of clavicle fractures. Infection Thirty-three (89%) studies reported infections rates in their results. Ten (30%) studies did report infection rates but did not use a definition for infection. Six (26%) studies defined superficial infection as in requiring antibiotics and 1 (4%) studies requiring re-intervention. For deep infections in one (5%) study definition involves required only antibiotics and in five (22%) studies re-interventions. (Table 6). Table 6. Definition infection used in literature Infection. Number of studies n=. Superficial infection Requiring antibiotics. 6. Requiring re-intervention. 1. No specification. 4. Deep infection Requiring antibiotics. 1. Requiring re-intervention. 6. No specification. 3. Infection Requiring antibiotics and/or re-intervention. 8. No definition. 10. Not reported. 4. DISCUSSION The most important findings of this study were that a wide variation in definitions is used in the management of clavicle fractures and in several of the included studies definitions were not reported at all. The diversity of currently applied definitions, if reported at all, reflects the lack of consensus. This stresses the need for standardization of definitions used in the management of (clavicle) fractures.5,52 In a systematic review of studies analyzing fracture healing in orthopedic trauma studies, the investigators reported that the majority of studies (62%) used a combination of clinical and radiographic criteria, while only radiographic criteria were used in 37% of the studies, and clinical criteria only in 1%.12 Plain radiography (an anterior-posterior [AP] view and a radiograph with a (15° - 45°) horizontal angle) is generally the most common way to assess fracture union radiological and a. 29. 2.

(31) Part I - Fundamentals of clavicle fractures. 2. substantial number of studies defined fracture union based on these radiographic parameters alone. In a review of 77 clinical studies on long-bone fracture healing, which used clinical criteria to define fracture union, the three most commonly used clinical criteria were absence of pain or tenderness when weight bearing (49%), absence of pain or tenderness on palpation or examination (39%) and the ability to bear weight (18%).12 When defining nonunion of clavicle fractures we found that 7 (50%) studies used only radiological criteria and 6 (43%) combined it with clinical criteria. The clinical criteria used were pain at the fracture site and motion or a gap present between the fracture parts. Herewith possibly excluding patients with an asymptomatic nonunion, which may influence study outcomes, the comparability of different studies and the timing of possible secondary interventions. Interestingly enough, more than half of the included studies (59%) did not describe a definition for nonunion. Besides the lack of a definition for the existence of a non-union, further dissimilarities are seen in assessing the time period for nonunion and delayed union. This varies from 4 months until 1 year for nonunion 2, 8, 10, 20, 31, 37, 40, 43, 51, 56-59, 61,63 and 3 months to 1 year for delayed union.10, 46, 51,57,58 This raises the question if there exists a difference between the two entities as described in the current literature at all. Another often discussed problem after surgical treatment of displaced midshaft clavicle fractures is implant-related irritation.25 In current literature a wide variation of reported irritation rates exist, ranging from 9% to 44% after plate fixation and 9% to 62% after IM nailing 25 and is mainly treated with surgical implant removal. In the studies included in this current review, the rationale for implant removal is often not clearly described. Implant related irritation does not always lead to implant removal and indications for implant removal vary; including implant-related irritation, implant failure, nonunion, patient’s preference, or surgeon’s preference to prevent future complications. Implant-related irritation is, thereby, a subjective endpoint and is influenced by a multitude of variables.. CONCLUSION At present a wide variety of definitions for disorders of clavicle fracture healing, adverse events or functional outcome exist making it difficult to compare study data. Therefore, we propose standardized definitions for the analysis of clavicle fracture management. These definitions, which are based on radiographic findings, and clinical examination, should provide a better determination of fracture union in the future. Until consensus is reached, we must be aware of the limitations of the methods that we currently use.. 30.

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(36) Definitions used in the management of clavicle fractures. 65. Woltz S, Krijnen P, Meylaerts SA, Pieterse AH, Schipper IB. Shared decision making in the management of midshaft clavicular fractures: Nonoperative treatment or plate fixation.Injury. 2017 Feb 27. pii: S0020-1383(17)30126-2. doi: 10.1016/j. injury.2017.02.032. [Epub ahead of print]. 67. Zehir S, Zehir R, Sahin E, Calbiyik M. Comparison of novel intramedullary nailing with mini-invasive plating in surgical fixation of displaced midshaft clavicle fractures. Arch Orthop Trauma Surg 2015;135:339-44. http://dx.doi.org/10.1007/ s00402-014 -2142-1. 66. Woltz S, Stegeman SA, Krijnen P, van Dijkman BA, van Thiel TP, Schep NW et al. Plate Fixation Compared with Nonoperative Treatment for Displaced Midshaft Clavicular Fractures: A Multicenter Randomized Controlled Trial.J Bone Joint Surg Am. 2017 Jan 18;99(2):106-112. doi: 10.2106/ JBJS.15.01394.. 35. 2.

(37) Part I - Fundamentals of clavicle fractures. Appendix 1 Search strings: Smeeing et al. Surgical Versus Nonsurgical Treatment for Midshaft Clavicle Fractures in Patients Aged 16 Years and Older Database. Searchstring. Hits. Pubmed. (clavicle[MeSH Terms] OR clavicle[Title/Abstract] OR clavicula[Title/Abstract] OR claviculae[Title/Abstract] OR clavicular[Title/Abstract] OR collarbone[Title/Abstract] OR collar bone[Title/Abstract]) AND (Fractures, bone[MeSH Terms] OR fracture[Title/Abstract] OR fractured[Title/Abstract] OR fractures[Title/Abstract]) AND (midshaft[Title/Abstract] OR mid shaft[Title/Abstract] OR midclavicular[Title/Abstract] OR mid clavicular[Title/Abstract] OR midclavicle[Title/Abstract] OR mid clavicle[Title/Abstract] OR middle third[Title/Abstract] OR mid third[Title/Abstract]) AND (surgery[subheading] OR Fracture Healing[MeSH Terms] OR Fracture Fixation[MeSH Terms] OR Surgical Procedures, Operative[MeSH Terms] OR Physical Therapy Modalities[MeSH Terms] OR orthopedics[MeSH Terms] OR orthopedics[Title/ Abstract] OR orthopaedics[Title/Abstract] OR surgery[Title/ Abstract] OR surgical[Title/Abstract] OR operative[Title/Abstract] OR operation[Title/Abstract] OR conservative[Title/Abstract] OR conventional[Title/Abstract] OR non-operative[Title/Abstract] OR nonoperative[Title/Abstract] OR sling[Title/Abstract] OR figureof-eight bandage[Title/Abstract]). 408. Embase. (‘clavicle’/exp OR clavicle:ti,ab OR clavicula:ti,ab OR claviculae:ti,ab OR clavicular:ti,ab OR collarbone:ti,ab OR ‘collar bone’:ti,ab) AND (‘fracture’/exp OR fracture:ti,ab OR fractured:ti,ab OR fractures:ti,ab) AND (midshaft:ti,ab OR ‘mid shaft’:ti,ab OR midclavicular:ti,ab OR ‘mid clavicular’:ti,ab OR midclavicle:ti,ab OR ‘mid clavicle’:ti,ab OR ‘middle third’:ti,ab OR ‘mid third’:ti,ab) AND (‘surgery’/exp OR surgery:ti,ab OR surgical:ti,ab OR operative:ti,ab OR operation:ti,ab OR ‘conservative treatment’/ exp OR ‘conservative treatment’:ti,ab OR conservative:ti,ab OR conventional:ti,ab OR ‘non-operative’:ti,ab OR nonoperative:ti,ab). 468. The Cochrane Library. (clavicle AND fracture). 94. CINAHL. (clavicle OR clavicula OR claviculae OR clavicular OR collarbone OR collar bone) AND (fracture OR fractured OR fractures) AND (midshaft OR mid shaft OR midclavicular OR mid clavicular OR midclavicle OR mid clavicle OR middle third OR mid third) AND (surgery OR surgical OR operative OR operation OR conservative OR conventional OR non-operative OR nonoperative). 110. 2. 36.

(38) Definitions used in the management of clavicle fractures. Search strings: Houwert et al. Plate fixation or intramedullary fixation for midshaft clavicle fractures: a systematic review and meta-analysis of randomized controlled trials and observational studies. Database. Searchstring. Hits. PubMed. (((((((surgery[Title/Abstract]) OR surgical[Title/Abstract]) OR operative[Title/Abstract]) OR operation[Title/Abstract])) AND (((((clavicle[Title/Abstract]) OR clavicular[Title/Abstract]) OR collarbone[Title/Abstract]) OR clavicula[Title/Abstract]) OR claviculae[Title/Abstract])) AND (((fracture[Title/Abstract]) OR fractured[Title/Abstract]) OR fractures[Title/Abstract])) AND ((((((((((midshaft[Title/Abstract]) OR mid shaft[Title/Abstract]) OR midschaft[Title/Abstract]) OR mid schaft[Title/Abstract]) OR mid clavicular[Title/Abstract]) OR midclavicular[Title/Abstract]) OR mid clavicle[Title/Abstract]) OR midclavicle[Title/Abstract]) OR middle third[Title/Abstract]) OR mid third[Title/Abstract]). 245. EMBASE. ‘surgery’/exp AND ‘clavicle fracture’/exp AND (‘midshaft’ OR ‘mid shaft’ OR ‘midschaft’ OR ‘mid schaft’ OR ‘mid clavicular’ OR ‘midclavicular’ OR ‘mid clavicle’ OR ‘midclavicle’ OR ‘middle third’ OR ‘mid third’) AND [embase]/lim. 313. Cochrane. Clavicle. 5. 2. 37.

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(40) CHAPTER THREE. Musculoskeletal modeling of midshaft clavicle fractures by using finite element analysis. D.J.C. van der Ven, A.M.L. Meesters, N.W. Schurink, G.D.J. van Olden, T.K. Timmers, K. H. Slump, I.A.M.J. Broeders Submitted.

(41) Part 1 - Fundamentals of clavicle fractures. ABSTRACT. 3. Introduction Biomechanical studies present contradicting results regarding the position for plate fixation of the clavicle. Therefore, the aim of this study was to develop a musculoskeletal model in which muscles and ligaments are included. The model was developed to evaluate the magnitude and the direction of forces acting on the clavicle during rehabilitation and daily activities. This information could be applied to investigate whether anteroinferior and superior plate fixation can withstand these forces without permanentdeformation or breakage and thus provides stable fixation. Methods An existing musculoskeletal model, the Delft Shoulder and Elbow Model, was used to calculate muscle, ligament, and joint reaction forces on the clavicle. A clavicle finite element model with a midshaft fracture was made. Muscles, ligaments, joint reaction, and gravitational forces were added to the finite element model. Models of the superior and anteroinferior plate were made. A simulation of the plates and the bone was done to determine the von Mises stress, the displacement, and the strain, for both abduction and anteflexion. Results The simulated von Mises stresses stayed below the yield strength. The von Mises stress is higher for anteroinferior plate fixation. The displacement and the strain are similar for anteroinferior and superior plate fixation. Conclusion The superior plating method has a lower von Mises stress and strain. Nevertheless, the difference in von Mises stress and strain with the anteroinferior plating is minimal. Both plating methods can withstand the forces without permanent deformation or breakage and therefore provide a stable fixation. However, validation of the model is needed, before a recommendation about the plate positioning can be made.. 40.

(42) Musculoskeletal modeling of midshaft clavicle fractures by using finite element analysis. INTRODUCTION Clavicle fractures are common in adults, accounting for 2.6-4% of all fractures. 1–5 This injury is caused by a direct axial compressive force to the shoulder after a sudden stop or fall, and commonly afflicts a young and active population. 3,6–9 The majority of fractures (69-80%) is located in the middle-third of the clavicle. 3,5,6,10 The s-shape of the bone and the anatomy of the ligaments/muscles attached to the clavicle make this part the most likely to fracture. 11 When the midshaft of the clavicle is fractured, muscles, ligaments, and the weight of the arm cause displacement of the bone parts. 5,8,11 Clavicle fractures have traditionally been treated conservatively, even when substantially displaced.5,9,12 However, there is evidence that nonunion incidence is higher than previously believed.4,12–19 Therefore, surgery should be considered as treatment option for displaced midshaft clavicle. Superior clavicle plating used to be the standard approach. Anteroinferior placement of the plate was introduced in an effort to decrease implant prominence, reducing the need for plate removal, and improve mechanical stability. However, there is still no consensus regarding the ideal position of the clavicle plate. 20 There are several in vitro biomechanical studies suggesting that superior placement of the plate is preferable,20–23 while the anteroinferior plate position is known for satisfactory clinical results.12,23–27 In both methods nonunion, refracture, hardware failure (screw pull-out, plate breakage, angulation or loosening), and deep infection are the most common complications.14,27,28 Only static tests were performed to investigate the ideal plate position in order to minimize complications. The primary aim of this study was to develop a musculoskeletal clavicle model in which all attached muscles and ligaments are included. The secondary aim was to use this in vivo based model to evaluate the magnitude and the direction of forces acting on the clavicle during rehabilitation and daily activities. Herewith determine which plate positioning can provide to most stable fixation.. METHODS Musculoskeletal modelling and finite element analysis (FEA) were used to determine the effects of activities of daily living on the clavicle. Also, plate stresses were determined for both superior and anteroinferior plate fixation. FEA is a numerical method, used to solve complex models with a lot of components. A mesh is calculated and material properties are defined. The mesh and properties determine how the object will react to forces. These forces can be chosen by the researcher and allow testing numerous movements, forces, plating orientations, fracture orientations, and bone mineralization, while keeping the rest of the. 41. 3.

(43) Part 1 - Fundamentals of clavicle fractures. 3. biomechanical characteristics of the clavicle constant. Firstly, muscles, ligaments, and joint reaction forces were calculated by using the Delft Shoulder and Elbow Model (DSEM, Delft University, The Netherlands). This is an inverse dynamics musculoskeletal model and uses EMG and joint angle data to compute the forces in the shoulder joint.29–34 EMG data, joint data, and force data were available for 6 ranges of motion movements and 5 activities of daily living.31 Shoulder abduction and anteflexion had our main focus. The model outputs were given as forces (in Newton) in the local coordinate system of the clavicle (Appendix I).Secondly, a clavicle finite element model (FEM) was made of the cortex (in SolidWorks 2016 x64 Edition, Dassault Systèmes S.A., Vélizy, France). The intermedullairy space was modelled as a cavity within the cortex. An oblique midshaft fracture was introduced into the model, by splitting the clavicle into two parts. The clavicle was meshed for FEA. Hereafter, ligaments (conoid, trapezoid and costoclavicular) (Figure 1A), muscles (deltoid, pectoralis major, and trapezius) and joint reaction forces were extracted from the DSEM. These forces were added to the clavicle model. In addition, a gravitational force was also added to the model (Figure 1B). The sternocleidomastoid muscle was not included in the DSEM. Therefore, this muscle was given a value of 145 Newton for anteflexion and 170 Newton for abduction, based on literature.35,36 Thirdly, models of a titanium anteroinferior (Figure 2A) and superior (Figure 2B) plate were made. These models are based on the plates of DePuy Synthes (the LCP Superior Clavicle Plate 3.5 mm, left 8 holes and the VA-LCP Anterior Clavicle Plate 2.7/3.5, 9 holes). The plate was centered on the bone, with an equal amount of locking screws on both sides of the fracture. Screw holes were made in the bone for bicortical fixation. Two simulations for both the plates and the bone (one for abduction and one for anteflexion) were made to determine the von Mises stress, the fracture displacement, and strain. These simulations were done for the clavicle with and without a fracture and for the situation in which the clavicle fracture has been fixated with the superior and anteroinferior positioned plates.. 42.

(44) Musculoskeletal modeling of midshaft clavicle fractures by using finite element analysis. A. B 3. Figure 1. A) A visualization of the fractured clavicle SolidWorks model with the ligaments (as fixed locations). Dark green: costoclavicular ligament, light blue: conoid ligament, light green: trapezoid ligament. Every point is fixed in the x-, y- and z-direction, indicated by three arrows. The disk at the start of the arrow indicates the fixation and the direction of the arrow indicates the direction in which the clavicle is fixed. B) A visualization of the fractured clavicle SolidWorks model with the forces. Only the conoid ligament is not shown, but this is shown in figure 3a. Light green: sternoclavicular joint reaction force, blue: sternocleidomastoid muscle, purple: pectoralis major muscle, black: gravity, yellow: trapezoid muscle, red: deltoid muscle, dark green: acromioclavicular joint reaction force. The direction of the arrow indicates whether the force pulls or pushes the bone. Note that, the arrows do not indicate the actual direction of the forces, except for the sternocleidomastoid muscle force and the gravity. The gravity has its point of action in the center of mass, which is located at the lowest point of the arrow.. A. B. Figure 2. A) A visualization (frontal view) of the clavicle, with the midshaft fracture and anteroinferior plate fixation. B) A visualization (top view) of the clavicle, with the midshaft fracture and superior plate fixation.. 43.

(45) Part 1 - Fundamentals of clavicle fractures. RESULTS Table 1 and 2 and Figures 2-5 in Addendum III show the force values of the DSEM that were used. Table 1. Force values for anteflexion, used in the finite element model. Force direction. 3. SC. AC. L. conoid. Pectoralis major. x. 68.29. y. 36.02. z. 40.81. Deltoid. Trapezoid. -106.22. 10.66. -21.54. -35.17. 16.35. 34.89. -16.48. -5.47. -18.33. 10.82. -21.22. 9.89. -5.65. -37.39. 5.66. SC: sternoclavicular joint, AC: acromioclavicular joint. A negative value means that the force is in the opposite direction. All values are in Newton.. Table 2. Force values for abduction, used in the finite element model. Force direction. SC. AC. L. conoid. Pectoralis major. Deltoid. Trapezoid. x. 39.38. -114.04. 12.09. 30.26. 45.62. -16.50. y. 30.28. -28.76. -30.83. 12.56. 20.10. 11.46. z. 47.80. -47.60. 8.33. 4.74. -16.91. 3.99. SC: sternoclavicular joint, AC: acromioclavicular joint. A negative value means that the force is in the opposite direction. All values are in Newton.. The displacement of the clavicle is visible after the fracture was simulated (Figure 3). The yield strength of cortical bone is 8.000 x 107 N/m2.37,38 The von Mises stress of the bone stays below the yield strength of cortical bone (with a fracture: 1.715 x 107 N/m2, without a fracture: 1.485 x 107 N/m2) (Figure 6 in Addendum III). The strain is similar with and without fracture (Figure 7 in Addendum III). The maximum von Mises stress of both the plate and the bone is higher for the anteroinferior (1.655 x 107 N/m2) plate position, compared to the superior (8.036 x 106 N/m2) position (Figure 8 in Addendum III). For both plates, the von Mises stress stays below the titanium plate yield strength (9.000 x 108 N/m2 for Ti-6Al7Nb).39,40 In the operative treatment of midshaft clavicle fractures stable fixation and anatomical repositioning of the fracture is needed (Figure 9 in Addendum III). Secondly, there was a similar strain for both the anteroinferior (5.946 x 10-4) and the superior (2.63 x 10-4) plate positions (Figure 10 in Addendum III). Therefore, stable fixation is provided by both plates.The distribution of the strain is similar to the distribution of the von Mises stresses (Figure 4). Therefore, the anteroinferior plate can break or deform easier, compared to the superior plate. The results of the simulation during anteflexion (Figures 11-15, 17 and 18 in Addendum III) are similar to the abduction results. 44.

(46) Musculoskeletal modeling of midshaft clavicle fractures by using finite element analysis. 3 Figure 3. A visualization of the displacement (in mm) of the clavicle, with the midshaft fracture, during abduction.. A. B. Figure 4. A) A visualization of the distribution of the strain of the anteroinferior plate fixation, with an adjusted scale, during abduction. B) A visualization (top view) of the distribution of the strain of the superior plate fixation, with an adjusted scale, during abduction.. 45.

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